Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05616260
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 50 years
* Body mass index ≤ 35 kg/m2
* Untreated OSA (AHI ≥10/h)
* Abnormal blood pressure (\>120/80mmHg, or on stable anti-hypertensive therapy for \>1month)
Exclusion Criteria:
* Substantial sleep hypoxemia (SpO2\<80% for \>10% of the monitoring time during the home sleep test, or for \>25% of the total sleep time during any of the in-laboratory studies)
* Severe uncontrolled hypertension (\>160/110mmHg during baseline assessment; \>180/120mmHg during follow up assessments)
* Abnormally low blood counts/electrolytes or renal function at baseline
* Mean use of OSA therapy ≥ 1h/night during past 1 month, or plans to urgently resume/(re)start clinical OSA therapy within 2 months
* Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder
* Other major sleep disorder (e.g., narcolepsy)
* Urgent need to initiate effective OSA therapy (i.e., Epworth sleepiness score \>18, commercial driver, prior sleep-related car accident, or based on MD judgment)
* Severe allergy to sulfa-drugs or taking another carbonic-anhydrase inhibitor (e.g., topiramate, zonisamide)
* Pregnancy/breastfeeding (current/planned)
* Prisoners
* Illicit substance abuse or \>2 standard drinks of alcohol/day
* Medications that may affect OSA or ventilatory control (e.g., opiates, sedatives)
* Thiazide/loop diuretic (risk of hypokalemia)
* Inability to give consent or follow procedures
* Safety concern based on MD judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05616260
Study Brief:
Protocol Section:
NCT05616260